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- Tasks: Lead CMC regulatory strategies for small molecule lifecycle management and ensure compliance.
- Company: Excelya, a dynamic team driven by Audacity, Care, and Energy.
- Benefits: Passionate work environment with opportunities for teamwork and professional growth.
- Other info: Collaborative culture with excellent career advancement opportunities.
- Why this job: Make a real impact in healthcare by guiding innovative small molecule products.
- Qualifications: Extensive CMC regulatory experience and strong knowledge of global frameworks.
The predicted salary is between 60000 - 80000 ÂŁ per year.
At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Senior CMC Regulatory Consultant specializing in small molecule lifecycle management to join our dynamic team. This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to post‑marketing activities. As a Senior Consultant, you will work closely with cross‑functional teams to ensure robust regulatory strategies, compliance, and submission excellence.
Main Responsibilities
- Lead the CMC regulatory strategy for all post‑approval lifecycle activities of assigned small‑molecule assets, providing proactive and timely regulatory guidance to technical teams.
- Manage and deliver all regulatory aspects related to Change Control requests, ensuring compliance with global regulatory requirements.
- Drive and coordinate project management activities supporting CMC post‑approval work, ensuring deliverables are completed on time, within scope, and at the required quality level.
- Liaise with local affiliates to define efficient and compliant regulatory strategies aligned with country‑specific requirements and agreed timelines.
- Represent CMC Regulatory in governance meetings and cross‑functional project forums.
- Write, review, compile, and submit CMC regulatory documentation in support of global post‑approval submissions, in accordance with regional requirements.
- Perform gap analyses and risk assessments to support regulatory strategy and readiness for submissions.
- Identify critical path activities, interdependencies, and rate‑limiting factors across technical and regulatory deliverables.
- Provide clear and regular status updates to internal and external stakeholders.
- Ensure effective document lifecycle management through the appropriate document management systems.
Candidate Profile
- Extensive experience in CMC regulatory affairs focused on small molecule lifecycle management, preferably within pharmaceutical industry or consultancy.
- Strong knowledge of global regulatory frameworks (EMA, FDA, ICH) and lifecycle management principles.
- Proven ability to lead CMC regulatory projects and collaborate with multidisciplinary teams.
- Excellent communication, analytical, and organizational skills.
- Degree in pharmacy, chemistry, pharmaceutical sciences, or related field.
- Fluency in English; French language skills are a plus.
Benefits
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Senior CMC Reg Consultant (Small Molecules Lifecycle) in London employer: Excelya
Contact Detail:
Excelya Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior CMC Reg Consultant (Small Molecules Lifecycle) in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the CMC regulatory field on LinkedIn or at industry events. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulatory frameworks. Be ready to discuss how your experience aligns with Excelya's focus on small molecule lifecycle management.
✨Tip Number 3
Showcase your project management skills! Be prepared to share examples of how you've successfully led CMC regulatory projects and collaborated with cross-functional teams.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, we love seeing candidates who are proactive!
We think you need these skills to ace Senior CMC Reg Consultant (Small Molecules Lifecycle) in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in CMC regulatory affairs, especially with small molecules. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects and achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about CMC regulatory work and how you can contribute to our team at Excelya. Keep it engaging and personal – we love to see your personality come through!
Showcase Your Communication Skills: Since this role involves liaising with various teams and stakeholders, make sure your application reflects your strong communication skills. Whether it’s through your writing style or examples of past collaborations, let us know you can connect with others effectively.
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It helps us keep track of applications and ensures you get the best experience possible. Plus, it shows you’re keen on joining our dynamic team!
How to prepare for a job interview at Excelya
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of CMC regulatory affairs, especially regarding small molecules. Familiarise yourself with the latest global regulatory frameworks like EMA and FDA guidelines, as well as lifecycle management principles. This will help you demonstrate your expertise and confidence during the interview.
✨Showcase Your Project Management Skills
Be ready to discuss your experience in managing CMC regulatory projects. Prepare specific examples where you successfully coordinated cross-functional teams and delivered on time. Highlight any challenges you faced and how you overcame them, as this will show your problem-solving abilities.
✨Communicate Clearly and Effectively
Since excellent communication is key for this role, practice articulating your thoughts clearly. You might be asked to explain complex regulatory concepts, so try to simplify them without losing the essence. This will showcase your ability to liaise with various stakeholders effectively.
✨Prepare for Scenario-Based Questions
Expect questions that assess your analytical skills and decision-making process. Think about potential scenarios related to change control requests or risk assessments and how you would handle them. This will demonstrate your proactive approach and readiness for the responsibilities of the role.